QUALIFICATION AND COMPUTER SYSTEM VALIDATION OF PHARMACEUTICAL INSTRUMENT: CRITICAL QUALITY ATTRIBUTES IN PHARMACEUTICAL INDUSTRYAbstract
Quality is the most important requirement in the manufacturing process for every pharmaceutical and healthcare industry. All the drugs must be manufactured to the highest quality level. Quality cannot be guaranteed just by end-product testing, but we have to control each critical step carefully during the manufacturing process. This qualification and computer system validation plays an important role in controlling each critical step of application in order to maintain the quality of the final product. Computer system validation involves a series of activities that are taking place during the life cycle of processes. It also involves careful planning of various stages in the qualification and validation of application/software used in the manufacturing process, and all the work should be carried out in a structured way according to standardized working procedures. The objective of this work is to overview the qualification and computer system validation of instrument/equipment used in the pharmaceutical industry.
S. Katre * and N. Jain
Department of Chemistry, Sri Satya Sai University of Technology & Medical Sciences, Sehore, Madhya Pradesh, India.
26 June 2020
07 September 2020
18 September 2020
01 October 2020